Container assembly and associated method

ABSTRACT

Container assembly including a container for storing a tissue sample and a cover adapted to engage with the container. The cover includes: a top member having a receptacle, a seal for sealing off the receptacle, a puncturing member for breaking the seal by displacement of the puncturing member. The container assembly has a first and a second position, wherein in the first position the container is isolated from the receptacle, and in the second position fluid communication is provided between the receptacle and the container. The container assembly includes a separator positioned between the seal and the bottom of the container, and the separator is provided with at least one aperture adapted to provide a fluid passage between the receptacle and the container.

CROSS-REFERENCE TO RELATED APPLICATION

This application is the U.S. national phase of PCT Application No.PCT/DK2011/050434 filed on Nov. 11, 2011, which claims priority to DKPatent Application No. PA 2011 70297, filed on filed Jun. 14, 2011, thedisclosures of which are incorporated in their entirety by referenceherein.

The present invention relates to a container assembly, more specificallyto a container assembly comprising: a container for storing a tissuesample, said container comprising a bottom, a cover adapted to engagewith said container, said cover comprising: a top member comprising areceptacle, said receptacle being adapted to contain a preserving agent,a seal for sealing off said receptacle, a puncturing member for breakingsaid seal by displacement of said puncturing member, where the containerassembly has a first and a second position, wherein in the firstposition the container is isolated from the receptacle, and in thesecond position fluid communication is provided between the receptacleand the container.

The invention further relates to a method of preserving a tissue sample.

Container assemblies for releasing an agent into a container at adesired point in time are well known and come in many shapes and sizes,both within the industry as well as within consumer goods.

In hospitals and clinics containers or Petri dishes are used forcollecting and storing tissue samples, such that after a tissue samplehas been taken from a patient, the tissue sample is placed in acontainer, and a preserving agent, often formalin, is subsequentlyfilled in the container before the container is closed and sent off to alaboratory for analysis. Here the container is usually opened in a fumecupboard as formalin and other preserving agents are toxic to inhale.The problem with this is that in the hospital the personnel taking thetissue sample, have to handle a preserving agent on a daily basis whenfilling the container. Usually a formalin dispenser station or adispenser mountable on the container temporarily is used. After theformalin has been dispensed into the container, the lid is mounted onthe container. Handling of a preserving agent this way may result inspillage and inhalation. Inhalation and other exposures constitute is ahealth hazard and handling of formalin and other preserving agentsshould be carried out with great care.

WO2004/000678 describes different embodiments of mixing vials, inparticular the embodiment depicted in FIGS. 6A-B show a mixing vialwhere a rigid rod is pressed through a supplemental container and thedilutant is entered into the container.

U.S. Pat. No. 5,152,965 describes an assembly of containers, comprisinga reagent vial and a container adapted to engage with an adapterassembly positioned between the two. The reagent vial contains a reagentto be mixed with a reagent diluent in the container. The adapterassembly comprises a coupler and a hollow plunger. The reagent vial isengageable with the coupler in a first position and is advanceable intoa second position relative to the adapter assembly such that the hollowplunger thereof displaces the seal of the reagent vial permitting thereagent to flow through the hollow plunger to mix with diluent in thecontainer.

The advancement of the coupler results in an increased pressure in thecontainer, which is undesirable as the increased pressure might resultin a spillage of the content in the container, when the adapter assemblyis removed from the container.

WO2008/040812 describes a receptacle configured to receive a volume ofpreserving agent, and a lid containing the preserving agent and beingadapted to be coupled to a tissue storage container. The preservingagent is entered into the lid through a one way valve. The lid furthercomprises a membrane with a number of holes. A plastic disc containingan equal amount of holes is placed between the receptacle and themembrane in the lid. When the holes are brought into alignment, e.g. bytwisting the lid, the preserving agent flows into the receptacle. Thisrequires that the container assembly is oriented such that the coverfacing upwards, thereby allowing the preserving agent to flow into thecontainer assisted by gravity.

The object of the present invention is to provide a container assemblywhere the risk of spillage and evaporation is considerably reduced andrisk of the sample getting stuck to the cover is eliminated.

In a first aspect, this is achieved by providing a container assemblycomprising a separator positioned between the seal and the bottom of thecontainer, and the separator is provided with at least one apertureadapted to provide a fluid passage between the receptacle and thecontainer.

By positioning the separator between the receptacle and the bottom ofthe container, it is ensured that the tissue sample does not get stuckto the top member or the puncturing means and at the same time that theseal does not interfere with the tissue sample. The tissue sample willusually be positioned at the bottom of the container.

According to a preferred embodiment the container assembly furthercomprising a space between the separator and the seal, the separatorbeing provided with a conduit adapted to provide a fluid passage betweenthe space and the container. This enables air from the container totravel upwards and thereby making it easier for the preserving agent toenter the container through the separator.

The conduit may have an opening positioned above the level of thepreserving agent after the seal has been broken. Thereby the air in thecontainer below the separator bypasses the preserving agent, making iteasier for the preserving agent to enter the container below theseparator.

The cover may constitute a lid. Instead of having to remove the coverafter having released the content in the receptacle, the cover may stayon the container and function as a lid, making it easy to transport.

The cover may comprise a membrane having a substantially convex shape inthe first position and a substantially concave shape in the secondposition. This membrane preferably covers the puncturing member. Thedifferent shapes of the membrane in the first and second position, makesit possible for the personnel to see from above if the seal has beenbroken.

The cover is preferably adapted to be fluid tightly sealed to thecontainer. This contributes to reducing the risk of spillage.

The cover may comprise a protective cap for covering the membrane.Thereby it is ensured that the membrane and thereby the puncturingmember is not pressed accidentally and the seal is not broken when it isnot intended to.

The container assembly may comprise a tracking device, such that thetissue sample can be tracked from where it was taken all the way to thelaboratory. The container assembly may also comprise a temperaturetracker, such that it is possible to see if the tissue has beensubjected to heat or cold, which may affect the tissue sample andconsequently the results of a test.

The puncturing member may be provided with at least one aperture, forproviding a passage between the space and the container. This eases theflow of the preserving agent into the container. The preserving agentmay flow around the puncturing member as well.

The separator may comprise a bottom and, engagement means for engagementwith corresponding engagement means of the cover, such that the bottomof the separator is prevented from contacting the bottom of thecontainer. The tissue sample does therefore not risk being pressed orsquashed when in the container and when the cover is removed forentering or taking out the tissue sample, the separator stays connectedto the cover and does not get in the way when handling the tissuesample. The engagement means may for example be threads or a snapclosure.

An outer diameter of the separator may be substantially equal to aninner diameter of the container, such that the separator and thecontainer substantially fit together and little fluid may bypass theseparator.

The seal may be selected from a group consisting of a film, a foil, amembrane and a polymer. These are all materials that are suitable to beeither punctured or cut or in any way penetrated, such that thepreserving agent may escape.

A part of the container assembly may comprise a transparent part forviewing inside the container. This enables the user of the containerassembly to visually inspect the sample to see if a proper preservationhas been carried out or whether the preserving agent has been releasedfrom the receptacle into the container.

The assembly may be provided with an indicator for indicating whetherthe seal has been broken. This can be seen as an indicator of whetherthe content of the receptacle has been compromised, if the seal has beendamaged contaminants might enter the receptacle, or whether the contentof the receptacle has been released and thereby alert the user. If thecontent has been released, the user knows that the container should notbe opened without taking different safety measures, such as opening thecontainer in a fume cupboard.

The separator is preferably a contrast colour, such as blue, to a colourof the tissue. This makes it easier the see the tissue sample if it getsstuck to the separator during transport e.g. to the laboratory.

The puncturing member may be provided with at least two projections forbreaking the seal, such that more holes are created it the seal and thepreserving agent may more easily leave the receptacle and enter thecontainer.

By providing the puncturing member with teeth, the seal may be broken orpierced in several places easing the flow of preserving agent into thecontainer.

The cover may be adapted to be locked to the container. This securesthat there cannot be any tampering with the tissue samples.

According to another embodiment the container assembly may comprise acontainer for storing a tissue sample, a cover adapted to engage withthe container, wherein the cover comprises: a top member comprising areceptacle, wherein the receptacle is adapted to contain a preservingagent, a seal for sealing off said receptacle, a punching or puncturingmember for breaking said seal wherein the seal is broken by displacingthe punching or puncturing member, a volume where the volume is definedby the interior of the outer walls of the container assembly, whereinthe punching or puncturing member is provided with engagement meansadapted to engage with corresponding engagement means provided on thetop member, such that the position of the punching or puncturing memberis adjustable independently of the orientation of the containerassembly, the container assembly has a first and a second position,wherein in the first position the container is separate from thereceptacle, and in the second position fluid communication is providedbetween the receptacle and the container, wherein the volume in thefirst position is the same as the volume in the second position. By notchanging the volume of the container assembly, the pressure inside thecontainer remains the same and thereby the risk of spillage when openedis considerably reduced.

The punching or puncturing member may be adapted to support the sealafter the seal has been broken. By letting the punching or puncturingmember support the seal the risk of parts of the seal slipping into thecontainer after the seal has been broken, and mixing with the contenthere, is reduced.

The cover may further comprise a ring member adapted to engage with saidcontainer. This ensures that the cover is connectable to the container.

The seal may be broken from outside of the receptacle. By not having tomount any punching or puncturing means within the receptacle, the riskof spillage during mounting of the cover is reduced and the risk of anycontaminants getting into the receptacle is reduced, and the shelf lifeof the assembly is increased.

The punching or puncturing member and the receptacle may be adapted tosubstantially fit together. This means that they are shaped such thatthey leave minimum room for anything being positioned between the two,except for the broken seal, when the punching or puncturing member hasbeen displaced to its terminal position. The terminal position isdefined as a position where the punching or puncturing member cannot bedisplaced further from its initial position. This reduces the risk ofany preserving agent flowing from the container back into the receptaclebehind the punching or puncturing member, thereby separating the tissuesample from the preserving agent.

At least a part of the space in the receptacle may form part of thespace in the container, when the cover is mounted on the container andthe seal has been broken. This means that the punching or puncturingmember is displaced such that when the seal has been broken, thepunching or puncturing member functions as a new separator between thereceptacle and the container and at least some of the space in thereceptacle now forms part of the container where the tissue sample maybe present.

The punching or puncturing member may only be able to advance when thecover is mounted on the container. This secures that the seal is notaccidentally broken, and the preserving agent may leak.

The punching or puncturing member may only be able to advance when thetop member is pushed down simultaneously with being turned. This securesthat even when the top member is mounted on the container, the seal isnot accidentally broken.

The cover may comprise resilient means for urging the punching orpuncturing member away from the receptacle. This enables the opening ofthe cover by simultaneously pushing and turning of the cover.Additionally it contributes to ensuring that the seal does not rest onthe punching or puncturing member and thereby increasing the risk ofunintentionally breaking the seal.

The receptacle may comprise an opening and a bottom, wherein thereceptacle may be tapered towards the bottom. By making the receptacletapered, a faster release of the preserving agent is obtained and it isnot possible for any of the preserving agent to not be released into thecontainer when the seal is broken. The receptacle may also be straightor cylindrical.

According to a second aspect a method of preserving a tissue sample,comprises the steps of: providing a container, filled with a preservingagent and sealed off by a seal, a puncturing member and a separator,placing a tissue sample in said container, engaging said cover with thecontainer thereby positioning said separator between the seal and thebottom of the container, displacing the puncturing member whereby saidseal is broken and the preserving agent is allowed to enter into thecontainer through the separator.

The puncturing member is preferably displaced by pressure on thepuncturing member.

A different method of providing a container assembly for containing atissue sample may be provided, comprising the steps of: providing acontainer, providing a cover including a top member with a receptacleand punching or puncturing member, filling said receptacle with apreserving agent, sealing said receptacle with a seal, placing a tissuesample in said container, engaging said cover with the container,displacing the punching or puncturing member by engaging engagementmeans of the punching or puncturing member with engagement means on thetop member of the cover, whereby the seal is broken and the preservingagent is entered into the container.

Any features from the first aspect may be incorporated into the secondaspect, and vice versa.

In the following, the invention will be described in further detail withreference to the drawings in which:

FIG. 1 shows a perspective view of the container assembly in a firstembodiment,

FIG. 2 shows an exploded view of the container assembly shown in FIG. 1,

FIG. 3 shows a detailed view of a cross section of the cover in thefirst embodiment,

FIG. 4 shows a cross section of the container assembly in a firstposition in the first embodiment,

FIG. 5 shows a cross section of a first embodiment of the containerassembly in a first position with the lid slightly pushed down,

FIG. 6 shows a cross section of a first embodiment of the containerassembly in a second position where the seal has been broken, and

FIG. 7 shows a view corresponding to FIG. 3 of the container assembly ina second embodiment,

FIG. 8 shows a perspective view of the container assembly in a thirdembodiment,

FIG. 9 shows a cross section of the container assembly in a firstposition in the third embodiment,

FIG. 10 shows a cross section of the container assembly in a secondposition in the third embodiment,

FIG. 11 shows a cross section of the container assembly in the thirdembodiment,

FIG. 12 shows a perspective view of the container assembly in a fourthembodiment,

FIG. 13 shows a cross section of the container assembly in a firstposition in the fourth embodiment.

FIG. 14 shows a cross section of the container assembly in a firstposition in a fifth embodiment.

FIG. 15 shows a cross section of the container assembly in a secondposition in a fifth embodiment.

FIG. 16 shows a cross section of the container assembly in a firstposition in a sixth embodiment.

FIG. 17 shows a cross section of the container assembly in a secondposition in a sixth embodiment.

FIG. 18 shows an exploded view the container assembly in a sixthembodiment as well as the container assembly in an assembled state.

FIG. 19 shows an exploded view the container assembly in a seventhembodiment as well as the container assembly in a perspective view in anassembled state.

FIG. 20 shows the container assembly in an assembled state in a seventhembodiment.

FIG. 21 shows a cross section of the container assembly in a firstposition in a seventh embodiment.

Like reference numbers refer to like features throughout the drawings.

FIG. 1 shows a container assembly generally designated 100 andcomprising a container 1 for containing a tissue sample and a cover 2 inan assembled state. In the embodiment shown the cover 2 comprises a ringmember 26, which is grooved for a firmer grip, and a top member 21. Thering member 26 may be provided with a rubber surface or simply with asmooth surface instead. The top member 21 is provided with projection(s)214 for making it easier to get a hold on the top member 21, when thetop member 21 is to be turned. The cover constitutes a lid, making thecontainer assembly easy to transport. In the embodiment shown thecontainer assembly is in an assembled state maximum 35 mm thick or deepor long on one of its sides, which makes it possible to send it in aletter. The container assembly may also be a maximum of 20 mm on one ofits sides, 25 mm on one of its sides or 50 mm on one of its sides. Thecontainer assembly may be larger on one of its sides, or even smaller onone of it sides. The receptacle in this embodiment is adapted to contain10 ml of preserving agent, such as formalin. The receptacle may be ableto contain a different amount of preserving agent, such as less than 15ml, less than 20 ml, less than 25 ml, less than 50 ml, less than 100 mlor less than 10 ml preserving agent or more than 100 ml of preservingagent. The container 1 is at least able to contain the correspondingamount of preserving agent as well as a tissue sample. A tissue samplemay take up up to 1 cm³, but is likely to be smaller, down to 1 mm³. Thetissue sample may be able to be covered by the preserving agent nomatter the orientation of the assembly.

FIG. 2 shows the different parts of the container assembly 100 in afirst embodiment. In addition to the top member 21, the cover comprisesa seal 22 in the form of a foil. The seal may also be a film, amembrane, a polymer, a composite material or glass. The top member 21 ismade of a polymer material, but may be made of other materials such asglass. In the embodiment shown the cover 2 further comprises a packing24 in the form of an O-ring for sealing the connection between the ringmember 26 and the top member 21. Other sealing means may be used.

Between a punching or puncturing member 23 and the top member 21 isresilient means 25 in the form of a spring positioned, for urging thepunching or puncturing member 23 away from the seal 22. In otherembodiments the resilient means 25 may be made of another resilientmaterial such as rubber or it may be in the form of flexible rodspositioned around the circumference of the punching or puncturing member23 or inside the top member 21 along the circumference of the receptacle211. The rods may be made of a polymer or a metal. The resilient means25 may be integrated with either the top member 21 or the punching orpuncturing member 23.

In this embodiment the punching or puncturing member 23 in the form of apunch or a plunger is provided with apertures 232 in an area of thepunching or puncturing member 23 that is adapted to enter the receptacle211. The apertures 232 contribute to facilitating a fluid communicationbetween the receptacle and the container 1. The punching member orpuncturing 23 may also, or alternatively, be provided with aperturesalong flange 233, which is not intended to enter the receptacle 211. Thepunching or puncturing member 23 is hollow but it may also be solid andprovided with one larger aperture or several smaller apertures forfacilitating a fluid communication between receptacle 211 and thecontainer 1. By making the punching or puncturing member 23 solid andmaking it fit together in shape with the receptacle 211 or onlyproviding the punching or puncturing member 23 with aperture(s) alongthe flange 233, the receptacle 211 is either almost filled by thepunching or puncturing member 23 or the connection between thereceptacle 21 and the container 1 is sealed off when the punching orpuncturing member 23 has reached its terminal position. This preventsthe preserving agent from becoming separated from the tissue sample.Only a minimal part or nothing of the preserving agent can flow backinto the receptacle 211 and into a space that is not reachable to thetissue sample, because the tissue sample may be larger than the providedapertures.

Finally the container assembly 100 comprises the container 1 adapted toengage with ring member 26. The engagement between the two can either bedone via threads or via a press on cover, by pressing a resilientcircumferential flange on the ring member 26 over a flange or otherprojections on the container 1 or vice versa. The ring member 26 is inthis embodiment used for holding the container 1 and the top member 21together and it contributes to controlling how far the top member 21 maybe pushed down.

The container 1 and/or the cover 2 may be provided with a transparentpart for viewing inside the container 1 to see if a tissue sample is inthe container 1 or if the seal 22 has been broken and the preservingagent is in the container 1. The container 1 and the cover 2 may beprovided with a locking mechanism to prevent tampering with the tissuesample on the way from the hospital to the laboratory. The lockingmechanism may be of a kind that may only be opened by the laboratorypersonnel or it may be an indicator showing if the assembly 100 has beenopened.

FIG. 3 shows a close up view of an embodiment of the cover 2 in anassembled state.

As shown in detail in this figure, the top member 21 is provided withthe receptacle 211 inside the top member 21 in the embodiment shown. Thetop member 21 is further provided with engagement means in the form ofindentations 213. These are adapted to engage with projections 261provided on the ring member 26. The engagement between the two retainsthe top member 21 in position as well as provides a safety margin of howfar down the top member 21 may be pushed. If such movement limitingmeans was not present it would be possible to accidentally press the topmember 21 and break the seal 22. Additionally the ring member 26 isprovided with projection(s) 262 that keep(s) the punching or puncturingmember 23 in place. In the embodiment shown the punching or puncturingmember 23 is provided with threads 231 that are adapted to engage withthreads 212 inside the top member 21. These make sure that the punchingor puncturing member 23 cannot merely be pushed from below, such thatthe seal 22 breaks unintentionally. When it is desired to break the seal22, the top member 21 is advanced such that the seal 22 breaks. In thisembodiment the top member 21 must be turned at the same time the topmember 21 is being pushed from above simultaneously with the punching orpuncturing member 23 being pushed from below. The punching or puncturingmember 23 is being pushed from below by the container 1. Before breakingthe seal 22 the cover 2 and the container 1 is preferably fluid tightlycoupled.

In the embodiment shown, the receptacle 211 is tapered such that theopening of the receptacle 516 is wider than the bottom 215. Thereceptacle may be other shapes such as cylindrical, pyramid shapedpolygonal or other shapes. Correspondingly the punching or puncturingmember may have the same shape.

In all of the embodiments the receptacle in the cover may be filled witha preserving agent at the site where the cover is being manufactured orat least before the cover is delivered to the user. The receptacle maybe filled with a preserving agent through the opening, which is latersealed off by the seal.

From the embodiment in FIG. 4 it can be seen how the punching orpuncturing member 23 rests on the edge of the container 1 and bymounting the cover 2 on the container 1 the punching or puncturingmember 23 is pushed slightly upwards. This makes sure that the punchingor puncturing member 23 is only able to advance when the cover 2 ismounted on the container 1. The engagement means 231 and 212 is stillnot able to engage if the top member 23 were turned. In this embodimentthe top member 21 must be pushed down as well. This added security thatthe top member 21 must be pushed down as well to break the seal 22 maybe left out.

Instead of advancing the engagement of the engagement means on the topmember 212 with the engagement means on the punching or puncturingmember 231, by turning the top member 21, it may be possible to have asudden release of the preserving agent, where the seal 22 is broken bypushing the top member 21 down without turning the top member 21. Inthis case the indentation 213 extends further upwards and does not stopthe projection 261 until after the seal 22 has been broken.

Between the ring member 26 and the container 1 a further packing (notshown) may be provided for added sealing between the two.

The broken line encircles the volume 110 that does not change duringbreaking of the seal 22. The volume 110 is defined by the interior ofthe outer walls of the container assembly 100. This is the interior wallof the top member 21, the ring member 23 and the container 1. Where theparts overlap, it is the parts being the most interior that define thevolume.

In FIG. 5 the top member 21 has been pushed down as can be seen on theengagement between the projection 261 and the indentation 213. Thepunching or puncturing member 23 is ready to engage with the top member21. By turning the top member 180-360 degrees the punching or puncturingmember is forced through the seal and the seal is broken. The seal 22 isbroken from below meaning that the punching or puncturing member 23 isoutside the receptacle 211 before the seal 22 is broken. The top membermay be turned more or less to break the seal 22 and to reach itsterminal position.

FIG. 6 shows the punching or puncturing member 23 in the terminalposition. The top part of the punching or puncturing member 23 above theflange 233 fits exactly into the receptacle 211. The top part of thepunching or puncturing member may be smaller or bigger than thereceptacle 211. After the seal has been broken, it is positioned betweenthe top member 21 and the punching or puncturing member 23, and the seal22 is prevented from entering into the container 1. The punching orpuncturing member 23 supports the seal 22 after the seal 22 has beenbroken. The seal 22 might also be of such a kind that upon puncturingthe seal draws out to the sides, leaving nothing but a ring of sealingmaterial along the edge of the opening of the receptacle 216. The spacethat is left when the punching or puncturing member 23 has reached itsterminal position is preferably less than 1/20 of the space in thereceptacle from opening 216 to bottom 215 or the distance from thebottom of the receptacle 215 to the punching or puncturing member 23 isless than 1 mm.

The FIGS. 1-6 show the different positions or states that the containerassembly may have.

In FIG. 1-3 a container, a cover is provided including a top member witha receptacle and punching or puncturing member. In FIG. 3 the receptacleis filled with a preserving agent and the receptacle is sealed. In FIG.4 a tissue sample (not shown) is placed in the possibly empty containerand the cover is brought into engagement with the container. In FIG. 5the top member is pushed down and in FIG. 6 the punching or puncturingmember is displaced by engaging engagement means of the punching orpuncturing member with engagement means on the top member. The seal isconsequently broken or punctured and the preserving agent is allowed toenter into the container.

FIG. 7 shows a container assembly in a second embodiment. The secondembodiment works as described for the first embodiment and the featureswith the same reference number are the same. The difference here is thatthe container 10 is extending up into the punching or puncturing member23. The punching or puncturing member 23 thereby has the option to reston the projection 262 on the container or on the edge of the container.So that it is either the projection 262 that pushes the punching orpuncturing member 23 up, or it is the edge of the container. By makingthe container extend into the punching or puncturing member thepersonnel opening the container assembly is better protected fromspillage as the wall above the level of preserving agent in thecontainer is higher.

FIGS. 8-11 shows a third embodiment of the invention. Referring to FIG.8, the assembly comprises a container 1 and a cover 2, the cover 2comprising a protective cap 27 and a top member 21. The purpose of theprotective cap 27 is to secure that the membrane (see FIGS. 9 and 10) isnot pressed unintentionally. The protective cap 27 may be pivotable orremovable. The top member 21 is provided with projections 29 for an easygrip and is removed from the container 1 by turning. The diameter Ø ofthis embodiment is 33 mm, but may be smaller or bigger. The height H is47 mm, but may be smaller or bigger. The receptacle 211 may be highersuch that more preserving agent may be contained. The receptacle 211 andthe container 1 should preferably be able to contain about 20 mlpreserving agent, respectively.

In FIG. 9 the assembly is in the first position and in FIG. 10 in thesecond position. The cross section in FIGS. 9-10 is taken along the lineA-A as shown in FIG. 8, and FIG. 11 is a cross section along the lineB-B also shown in FIG. 8. The container 1 is adapted to receive a tissuesample 45, and the cover comprises a top member 321. A separator 31 isprovided between the seal 22 and the bottom 13 of the container. In thisway, in a mounted state with the cover attached the container 1, thecontainer 1 is separated into two spaces, a first 11 and a second 12space. Even though the spaces 11, 12 are separated does not necessarilymean that the separator 31 and the container 1 are fluid tightly sealed.Fluid may be prevented from bypassing the separator 31. Fluid may alsobypass the separator 31 instead of traveling though the separator 31.The inner circumference of the container 1 is of substantially same sizeas the outer circumference of the separator 31, but the innercircumference of the container 1 may be slightly bigger than the outercircumference of the separator 31.

Referring to FIGS. 9-10, the top member 321 is provided with engagementsmeans 324, such as threads, for engagement with the container 1. Thecontainer 1 is likewise provided with engagement means 325, here in theform of threads for engagement with the corresponding threads on the topmember 321. The engagement between the top member 321 and the container1 may alternatively be accomplished by means of a snap closure.Furthermore the top member 321 is provided with engagement means 326 forengagement with the puncturing member 323. The engagement means 326 isin the form of four slits in a hollow cylindrical shape that is adaptedto receive the puncturing member 323. The cylindrical shape may be solidand/or the number of slits may be varied. Engagement means in the formof a snap lock may be provided instead. Furthermore the top member 321may be provided with engagement means 327 for engagement with engagementmeans 328 provided on the inner side of the separator 31. Hereby theseparator 31 stays attached to the cover 2 when the cover 2 is removedfrom the container 1, e.g. for taking out a tissue sample. Theengagement means 327, 328 may be in the form of threads or a snapclosure.

On top of the top member 321 the membrane 28 is positioned. In FIG. 9 ithas a substantially convex shape and in FIG. 10 it has a substantiallyconcave shape. When the pressure is removed from the membrane 28, themembrane 28 will keep its concave shape. This allows personnel to seefrom above if the preserving agent has been released. As the container 1is preferably see-through, it may also be seen through the container 1if the preserving agent has been released. The membrane 28 may be aspring membrane that automatically bounces back to its first position.The puncturing member 323 is activated by pressing the membrane 28.Thereby the puncturing member 323 is displaced along the longitudinalaxis of the assembly, and the seal 22, separating the receptacle 211from the container 1, is ruptured or broken.

In the embodiment shown, the puncturing member 323 is provided withteeth 329 for piercing the seal 22. The puncturing member 323 is made ofa polymer material, but may also be made of metal or other suitablematerials. An additional piercing element 330 for breaking through theseal 22 is provided, but may be dispensed with.

The seal 22 may be a foil, a film or a polymer membrane.

The separator 31 is adapted to hang from the cover 2. At the bottom 13of the separator 31 a grid is provided. The separator 31 should be ableto let the preserving agent through, and while at the same time ensuringthat the seal 22 does not enter the container 1 and securing that thetissue sample 45 does not migrate into the receptacle 211 duringtransport.

Referring to FIG. 11, the apertures 291 in the grid in the separator 31are squares, each approx. 1 mm in transverse size, but may be smaller orbigger, circular or polygon-shaped. The grid is permeable for a liquidwith a surface tension similar to that of water. Another kind ofpermeable membrane may also be used. The separator 31 may be providedwith apertures elsewhere, such as in the walls of the separator 31. Theseparator 31 is not a container for the tissue sample such as acassette, but instead separates the container 1 in two interconnectedspaces. The second space 12 and/or the bottom of the container 1 isadapted to receive the tissue sample 45. The first space 11 may also bepositioned in the cover 2. Referring to FIGS. 9-11 the separator 31 isfurthermore provided with a conduit 30 with an opening or air inlet atthe bottom of the separator 31 and an opening or an air outletpositioned at a distance from the air inlet. The air outlet ispositioned such that when the seal 22 has been broken and the preservingagent has left the receptacle 211, the preserving agent may not pass thegrid due to the smallness of the apertures and the surface tension ofthe agent, without for example shaking the assembly. The permeability ofthe grid can be increased by means of the conduit 30 that allows air inthe container 1 to bypass the preserving agent through the conduit 30and thereby letting the preserving agent pass through the apertures 291in the grid. The opening or air outlet is therefore positioned such thatit is above the level of the preserving agent when the seal 22 has beenbroken. Two conduits 30 are provided in this embodiment, but one of morethan two conduits 30 and other shapes of conduits may be providedinstead. The separator 31 or at least the grid is blue or another colourof contrast to a tissue sample. This makes it easier to see a tissuesample in case it clings to the separator 31. The separator may be othercolours. The space 12 for the tissue sample 45 is positioned below theseparator 31. The assembly may be provided with a tracking device suchas an RFID (radio frequency identification) tag, such that the samplecan be tracked from collection to test in a laboratory. The sample 45need not be covered by the preserving agent at all times, since thefumes in the container 1 will usually be enough to preserve the sample45.

FIGS. 12 and 13 show a fourth embodiment of the invention in the form ofcontainer assembly 400. FIG. 13 shows a cross section of the assemblyalong the line A-A as shown in FIG. 12. All the features and functionspresent in the third embodiment are likewise present in the fourthembodiment where the same reference numbers indicate similar features.The difference between the third and the fourth embodiment is that thefourth embodiment is higher and is able to contain around 20 ml offormalin or other preserving agent both in the receptacle 211 and in thecontainer 1. The conduit(s) 30 has in this embodiment not been madelonger as it takes some time before the preserving agent passes theseparator 31 and thereby the conduit(s) 30 will still be above the levelof the preserving agent when the seal 22 has been broken. The conduit(s)30 may be made longer, such as between 2-5 cm long. Any size ofcontainer able to contain between about 5-50 ml of preserving agent canbe imagined.

FIGS. 14 and 15 show a fifth embodiment of the invention in the form ofcontainer assembly 500. All the features and functions present in thethird and fourth embodiments are likewise present in the fifthembodiment where the same reference numbers indicate similar features.In FIG. 14 the assembly 500 is in a first position and in FIG. 15 theassembly is in a second position. In addition to similar features asthose described in the third and/or fourth embodiments, the containerassembly 500 further comprises a removable cap 528 provided withgripping parts 548. The cap 528 protects the membrane 28 from pressureduring transport.

FIGS. 16-18 show a sixth embodiment of the invention in the form ofcontainer assembly 600. The container assembly 600 differentiates itselfamong others from the third embodiment in that the top member 621 istaller and is able to contain more preserving agent. The punching orpuncturing member 323 is also taller and is provided with a cross shapedor T-shaped projection 626 at the top. The projection 626 rests at acircumferential flange 627 provided on the top member 621. Thereby whenthe membrane 28 is pushed down, the projection is forced pass thecircumferential flange 627 upon which it rested in its initial position.The circumferential flange 627 or the projection 626 may have resilientproperties, which allow the projection 626 to pass the circumferentialflange 627. The projection 626 may be tapered such that it can bepressed pass the flange 627 more easily. The circumferential flange 627may also be in the form of circumferential projections that are notconnected along the whole circumference. The top member 621 isconnectable to the container 1 such that the exterior of the top member621 engages with the interior of the container 1. It may also be viceversa. The top member 621 and container 1 may be provided withengagement means in form of threads.

Furthermore the separator 31 is provided with conduit(s) 31 in the formof segments. By extending the wall of the conduit(s) across theseparator 31 as a chord, the separator 31 gets more rigid. Theconduit(s) 30 do(es) not extend above the top edge of the separator 31,but may do so in other embodiments.

The top member 621 extends above the highest point of the membrane 28 ina first position, thereby protecting the membrane 28 from pressure whenno protective cap is provided. The highest point in this embodiment isthe center of the membrane.

The sixth embodiment may further comprise any of the features from thethird, fourth and fifth embodiment.

FIGS. 19-21 show a seventh embodiment of the invention. In addition tothe features in the sixth embodiment the container assembly 700 isadditionally provided with a cap 728. The top member 721 does not extendbeyond the highest point of the membrane 28 as it does in the sixthembodiment. The seventh embodiment may contain any of the features fromthe third, fourth, fifth and sixth embodiment.

By “broken” is meant that a hole has been created in the film or sealwhere either the preserving agent may flow out or particles orcontaminants from the outside may enter.

The term “cover” as used herein includes all means that cover theopening of a container. The term “separator” is used for a member usedto separate the seal from a potential tissue sample placed in thecontainer. In some embodiments the separator also functions as thepunching or puncturing member, such that the separator and the punchingmember form one element, while in other embodiments the puncturingmember and the separator are separate elements.

The word “container” is generally used about the container or space thatis adapted to contain the tissue sample.

Furthermore, it is conceivable to make use of other configurations ofthe container assembly. It may be of industrial size where the containeris able to contain at least 1 L or less than 5 L, 10 L, 100 L, 1000 L ormore. The container may contain a substance which is to be mixed with asecond substance with less of a volume. The cover or lid may be able tocontain the second substance, with a volume of less than 5 ml, 10 ml, 30ml, 50 ml, 100 ml or more than 100 ml, which is to be mixed with thesubstance in the container. The second substance may be a toxic orvolatile substance or a substance where it is important that the exactamount of substance is entered into the container. This larger sizedcontainer assembly may have the same features as the first, second,third or fourth embodiment. Any feature of these embodiments may beapplied independently of each other to this larger sized containerassembly.

In general, the features of the embodiments shown and described may becombined freely and no feature should be seen as essential unless statedin the independent claims.

The invention claimed is:
 1. A tissue-sample container assemblycomprising: a container defining a cavity for storing a tissue sample; acover adapted to engage with the container to close the cavity, thecover including a top member having a receptacle adapted to contain apreserving agent and a seal for sealing off said receptacle, andincluding a puncturing member for breaking the seal by displacement ofthe puncturing member relative to the seal; and a separator disposedwithin the cavity between the seal and a bottom of the cavity, whereinthe separator defines at least one aperture adapted to provide a fluidpassage between the receptacle and the bottom of the cavity wherein theseparator is oriented, and the at least one aperture is sized, tomaintain the tissue sample between the bottom and the separator.
 2. Thecontainer assembly according to claim 1, further comprising a spacebetween the separator and the seal, the separator being provided with aconduit adapted to provide a fluid passage between the space and thecontainer.
 3. The container assembly according to claim 2, wherein theconduit has an opening positioned above the level of the preservingagent after the seal has been broken.
 4. The container assemblyaccording to claim 2, wherein the puncturing member is provided with atleast one aperture, for providing a passage between the receptacle andthe space.
 5. The container assembly according to claim 1, wherein thetop member further comprises a membrane defining an outer surface of thetop member and having a substantially convex shape in a first positionand a substantially concave shape in a second position.
 6. The containerassembly according to claim 5, wherein the cover comprises a protectivecap for covering the membrane.
 7. The container assembly according toclaim 1, wherein the receptacle and seal cooperate to define anenclosure and a preserving agent is disposed within the enclosure. 8.The container assembly according to claim 1, wherein the containerassembly comprises a tracking device.
 9. The container assemblyaccording to claim 1, wherein the separator comprises a bottom andengagement means for engagement with corresponding engagement means ofthe cover, such that the bottom of the separator is prevented fromcontacting the bottom of the container.
 10. The container assemblyaccording to claim 1, wherein an outer diameter of the separator issubstantially equal to an inner diameter of the container.
 11. Thecontainer assembly according to claim 1, wherein the seal is selectedfrom a group consisting of a film, a foil, a membrane and a polymer. 12.The container assembly according to claim 1, wherein a part of thecontainer assembly comprises a transparent part for viewing inside thecontainer.
 13. The container assembly according to claim 1, furthercomprising an indicator for indicating whether the seal has been broken.14. The container assembly according to claim 1, wherein the separatoris a contrast colour compared to a colour of the tissue.
 15. Thecontainer assembly according to claim 1, wherein the puncturing memberis provided with at least two projections for breaking the seal.
 16. Thecontainer assembly according to claim 1, wherein the puncturing memberis provided with teeth.
 17. The container assembly according to claim 1,wherein the cover is adapted to be locked to the container.
 18. Thecontainer assembly according to claim 1, wherein the separator isincluded in the cover.
 19. A method of preserving a tissue sample,comprising the steps of: providing a container, providing a coverincluding a top member with a receptacle filled with a preserving agentand sealed off by a seal, a puncturing member and a separator, placing atissue sample in said container, engaging said cover with the container,thereby positioning said separator between the seal and a bottom of thecontainer, and displacing the puncturing member whereby said seal isbroken and the preserving agent is allowed to enter into the containerthrough the separator.
 20. The method of claim 19 wherein the tissuesample is immersed in the preserving agent in response to displacing thepuncturing member.
 21. A container assembly for a tissue sample, thecontainer assembly comprising: a container defining an open top and anopen cavity configured to store a tissue sample; and a removable lidconnectable to the open top of the container such that the cavity isclosed when the lid is connected, the lid including a top defining areceptacle, a membrane disposed over the receptacle to seal thereceptacle, a preserving agent disposed in the receptacle, and apuncturing member axially displaceable relative to the top between atleast a first position and second position, wherein movement of thepuncturing member to the second position causes the puncturing member tobreak the membrane releasing the preserving agent into the open cavity.